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Doseworth

FDA warning letter · #716502

Tuyo Health: What the FDA Letter Means for What You Pay

Legal name: Tuyo Health, Inc.

Activesemaglutidetirzepatide
Status

Operating

Concerns

marketing / labeling

Issued

September 2025

Response logged

Not logged

By Marla Whitfield, Pricing Editor

Primary source

Read the original letter on fda.gov →

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tuyo-health-inc-dba-tuyo-health-716502-09092025

What FDA cited

Quoted verbatim from the letter dated

Read the full letter →

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.tuyohealth.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.

  1. 1

    The following claims concerning compounded semaglutide and tirzepatide products appear on your website:

  2. 2

    “Same active as Wegovy and Ozempic” “Same active ingredient as Zepbound and Mounjaro” “With compounded semaglutide, you get the same trusted active ingredient as in brand-name medications….”

  3. 3

    Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.

Process

How a warning letter proceeds

  1. 1

    Letter issued

    September 2025

  2. 2

    15-working-day response window

    FDA gives the company 15 working days to respond in writing.

  3. 3

    Close-out, if issued

    FDA may post one once it is satisfied the cited issues have been corrected.

Is Tuyo Health still operating?

tuyohealth.com returned a live storefront on 2026-08-09, titled "Tuyo Health | Online Telehealth Clinic for ED, Weight Loss & More", carrying published prices and a payment integration, so the site was transacting at that check.

What this means for what you pay

Read the three claims in order and you can watch a chemistry statement turn into a reputation statement. "Same active" is a fact about a molecule. "Same trusted active ingredient as in brand-name medications" borrows something the molecule does not carry: the trials, the approval file, the years of post-market reporting that made the brand-name product trusted in the first place. None of that follows the ingredient into a compounded vial. FDA's objection was to the impression of sameness, not to the medicine or the price, and the practical lesson for a price comparison is narrow but real — when a cheaper option leans on the brand's credibility rather than its own, you are being asked to price in something the seller has not actually bought.

Has Tuyo Health responded?

As of , FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence Tuyo Health failed to respond.

Sources

Other letters in this index

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Editorial disclaimer: An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.